ExtubationNCT05837936
Total Intravenous Anesthesia (TIVA)/Sevoflurane Initiated Intravenous Anesthesia (SIIVA) in Pediatric Patients
An observational study of Extubation, run by Wake Forest University Health Sciences at 2 sites in 2 countries.
Trial summary
Because Propofol is the primary "anesthetic agent," and inhalational agents remain in trace quantities at the end of the procedure Sevoflurane initiated intravenous anesthesia (SIIVA) or not present at all Total intravenous anesthesia (TIVA) it is likely that different criteria may be predictive of extubation success… Read more about this study
- Who is it for?
- Ages Up to 9 years
- Conditions the study is for
- Extubation
- What is being tested?
- Total intravenous anesthesia (TIVA) and Sevoflurane initiated intravenous anesthesia (SIIVA)
- Type of treatment
- Injection or infusion
- How many people
- 600 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Mar 2023to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: All study participants must be < 10 years of age and undergoing general anesthesia and surgery with an endotracheal tube and using a SIIVA or TIVA approach
Who may be able to join
- Pediatric patients <10 years of age
- Undergoing elective or emergency surgery with planned airway instrumentation with an endotracheal tube (ETT)
- Patients having general anesthesia with a planned SIIVA or TIVA technique
- Patients with an end tidal agent concentration of Sevoflurane<0.1% at the time of emergence and extubation
- following sevoflurane induction to place IV
Who cannot join
- History of home oxygen use or ventilator dependence
- Patients with cyanotic congenital heart disease
- Patients undergoing anesthesia for imaging procedures alone
- Patients intended to be managed with supraglottic airway
- Patients having an anesthesia time < 30 minutes
- Monitored Anesthesia Care (not general anesthesia)
- Patients with contraindication to receiving Propofol (i.e. mitochondrial myopathy)
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Thomas "Wes" Templeton, MD, 336-716-4498, ttemplet@wakehealth.edu
Lynnette C Harris, BSN, 336-716-8791, lcharris@wakehealth.edu
Australia1 site, 1 recruiting
- Not yet recruiting
Perth Children's Hospital
Perth
Britta von Ungern-Sternberg, Prof, +61(0)8 6456 4806
Lliana Slevin, +61(0)8 6456 4806, Lliana.Slevin@health.wa.gov.au
About this study
Official title: A Prospective Observational Study Evaluating Extubation Criteria in Children Less 10 Years of Age and Younger Undergoing Intravenous Anesthesia
Because Propofol is the primary "anesthetic agent," and inhalational agents remain in trace quantities at the end of the procedure Sevoflurane initiated intravenous anesthesia (SIIVA) or not present at all Total intravenous anesthesia (TIVA) it is likely that different criteria may be predictive of extubation success in these patients compared to inhalational anesthesia.
Read the detailed description
This is because these anesthetic regimens have different pharmacologic mechanisms of actions, and therefore interact with central nervous system in different ways leading to potentially the need for different extubation criteria in patients receiving TIVA or SIIVA. Additionally, intravenous agents likely have less of an effect on airway reflexes and ventilation at light levels of anesthesia. This study is proposing an observational study to examine the predictive value of various extubation criteria in the setting of SIIVA and TIVA.
- Conditions
- Extubation
- Being tested
- Total intravenous anesthesia (TIVA), Sevoflurane initiated intravenous anesthesia (SIIVA)
- Keywords
- anesthesia, Propofol, inhalational agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total intravenous anesthesia (TIVA)Other
TIVA anesthetic -no inhalational gases for surgery
Sevoflurane initiated intravenous anesthesia (SIIVA)Other
SIIVA - sevoflurane anesthetic gases for surgery
| Study group | Role | What they receive |
|---|---|---|
| Total intravenous anesthesia (TIVA) | TIVA is achieved without inhalational agents and may be performed in cases where patients have an intravenous line in place prior to induction of anesthesia Receives: Other: Total intravenous anesthesia (TIVA) | |
| Sevoflurane initiated intravenous anesthesia (SIIVA) | SIIVA is a modification of TIVA in the setting where a patient does not tolerate the insertion of an intravenous line prior to induction of anesthesia. The patient undergoes induction of anesthesia with sevoflurane and transition to Propofol IV anesthesia for maintenance once the intravenous line is in place and discontinues the inhalational agent, sevoflurane. Receives: Other: Sevoflurane initiated intravenous anesthesia (SIIVA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation success rate
quality of extubation will be assess using a standard rubric for all extubation
Measured: Day 1
Secondary outcomes (1)
Rate of extubation that requiring intervention
desaturation, laryngospasm, airway obstruction or other issues
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start28 Mar 2023
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExtubationStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas "Wes" Templeton, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837936
- Sponsor's protocol ID
- IRB00092312
- Status last verified
- Dec 2025
- First submitted
- 3 Apr 2023
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study Evaluating Extubation Criteria in Children Less 10 Years of Age and Younger Undergoing Intravenous Anesthesia
- ClinicalTrials.gov ID
- NCT05837936
- Acronym / sponsor ID
- IRB00092312
- Conditions
- Extubation
- Keywords
- anesthesia, Propofol, inhalational agents
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Because Propofol is the primary "anesthetic agent," and inhalational agents remain in trace quantities at the end of the procedure Sevoflurane initiated intravenous anesthesia (SIIVA) or not present at all Total intravenous anesthesia (TIVA) it is likely that different criteria may be predictive of extubation success in these patients compared to inhalational anesthesia.
Detailed description
This is because these anesthetic regimens have different pharmacologic mechanisms of actions, and therefore interact with central nervous system in different ways leading to potentially the need for different extubation criteria in patients receiving TIVA or SIIVA. Additionally, intravenous agents likely have less of an effect on airway reflexes and ventilation at light levels of anesthesia. This study is proposing an observational study to examine the predictive value of various extubation criteria in the setting of SIIVA and TIVA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total intravenous anesthesia (TIVA) | – | Other: Total intravenous anesthesia (TIVA)TIVA is achieved without inhalational agents and may be performed in cases where patients have an intravenous line in place prior to induction of anesthesia |
| Sevoflurane initiated intravenous anesthesia (SIIVA) | – | Other: Sevoflurane initiated intravenous anesthesia (SIIVA)SIIVA is a modification of TIVA in the setting where a patient does not tolerate the insertion of an intravenous line prior to induction of anesthesia. The patient undergoes induction of anesthesia with sevoflurane and transition to Propofol IV anesthesia for maintenance once the intravenous line is in place and discontinues the inhalational agent, sevoflurane. |
Who may qualify
- Ages
- Up to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All study participants must be < 10 years of age and undergoing general anesthesia and surgery with an endotracheal tube and using a SIIVA or TIVA approach
Key inclusion criteria (5 listed)
- Pediatric patients <10 years of age
- Undergoing elective or emergency surgery with planned airway instrumentation with an endotracheal tube (ETT)
- Patients having general anesthesia with a planned SIIVA or TIVA technique
- Patients with an end tidal agent concentration of Sevoflurane<0.1% at the time of emergence and extubation
- following sevoflurane induction to place IV
Key exclusion criteria (7 listed)
- History of home oxygen use or ventilator dependence
- Patients with cyanotic congenital heart disease
- Patients undergoing anesthesia for imaging procedures alone
- Patients intended to be managed with supraglottic airway
- Patients having an anesthesia time < 30 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total intravenous anesthesia (TIVA)TIVA anesthetic -no inhalational gases for surgery | Other | Total intravenous anesthesia (TIVA) |
| Sevoflurane initiated intravenous anesthesia (SIIVA)SIIVA - sevoflurane anesthetic gases for surgery | Other | Sevoflurane initiated intravenous anesthesia (SIIVA) |
Primary outcome
Extubation success rate
Time frame: Day 1
quality of extubation will be assess using a standard rubric for all extubation
1 secondary outcome
Rate of extubation that requiring intervention
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas "Wes" Templeton, MD principal investigator
Wake Forest University Health Sciences
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extubation, run by Wake Forest University Health Sciences at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wes Templeton, MD (336-716-4498, ttemplet@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation success rate (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.